Biotechnology Basics (T18)

This fundamental course is ideal for professionals that are new to the biotechnology industry, professionals entering new work assignments encompassing biotechnology operations, or individuals with previous pharmaceutical industry experience that want to learn the basics of biotechnology. This is a course that is ideal for individuals involved in human resources, economic development, and business and strategic planning efforts. Professionals in quality control, quality assurance, and technical management support will also find it beneficial.

Participants in this course will explore the history of the biotechnology industry and will learn the fundamental concepts of biotechnology science. Participants will also learn basic terminology and how it is applied in the industry. The course will identify basic process science and unit operations for the manufacture of products and will describe the regulatory foundation that makes biological products different from traditional pharmaceutical products. There will be discussions to evaluate emerging technologies and how they will impact the industry. The course will also classify validation issues surrounding compliance with GMP and define basic requirements for facilities that manufacture biological products.

The course will present information on:

The history of the biotechnology industry

The science behind the industry

Products

Application of technology

Process unit operations

Regulatory aspects

Facilities and equipment

Industry trends and issues

Course Modules

Biotechnology - The Science

Bioprocess Basics

Other Manufacturing Techniques

The Biotech Industry Today

The GMPs

Regulatory Review

Understanding Biotech Facility Design

Facility Attributes

Defining the Biotech Project

Industry Trends and Issues

Includes Webinar

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the Webinar one week prior to the start of the training event.

Webinar Learning Objectives

Describe biological products and manufacturing processes

Explain regulatory philosophy

Discuss facility design concepts within the biotechnology industry

Take Back to Your Job

Describe the history of the biotechnology industry

Cite fundamental concepts of biotechnology science

Utilize basic terminology

Identify basic process science and unit operations for the manufacture of products

Describe the regulatory foundation that makes biological products different from traditional pharmaceutical products